Medical Device Recall Information - Philips Respironics Sleep and Respiratory Care devices Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices 3,950,000 repair kits and replacement devices produced to date globally 2,000,000 devices shipped in the US Is there a question we can answer for you? Be aware that during the manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs). The foam cannot be removed without damaging the device. Although MDRs are a valuable source of information, this passive surveillance system has limitations. If you use a Philips Respironics CPAP or BiPAP device that is included in the recall, continue using your device as prescribed until a new device is available. For patients using life-sustaining ventilation, continue prescribed therapy. Read more in the safety communication for Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris. Register your product and start enjoying benefits right away. Please switch auto forms mode to off. You can log in or create one. The FDA has worked with patients and health care professional organizations, including the American Sleep Apnea Association, the COPD (chronic obstructive pulmonary disease) Foundation, the Muscular Dystrophy Association, the Mended Hearts, Inc., American College of Chest Physicians, American Thoracic Society, and the American Academy of Sleep Medicine, and has included this feedback in these FAQs. 2. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. You are about to visit a Philips global content page. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. Creating a plan to repair or replace recalled devices. We may need more information from you or you may have other options available to you, including alternative replacement devices or financial payment, dependent on your specific situation. Office of Accountability & Whistleblower Protection, Training - Exposure - Experience (TEE) Tournament, Chief Resident in Quality and Patient Safety, About the National Center for Patient Safety, War Related Illness & Injury Study Center, Clinical Trainees (Academic Affiliations), https://www.philipssrcupdate.expertinquiry.com, Call TTY if you Koninklijke Philips N.V., 2004 - 2023. An official website of the United States government. I need to change my registration information. 1. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 0 Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers The results from the independent testing are needed to determine if the silicone-based foam used in the repaired devices does in fact present any risks to patients. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. Create account Create an account Already have an account? CDRH will consider the response when it is received. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. 2. We may request contact information, date of birth, device prescription or physician information. UPDATE - February 9, 2023: The FDA updated this safety communication to provide updated information about medical device reports (MDRs) that the FDA received from November 1, 2022, to December 31, 2022, and are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021. For further information about your current status, please log into the portal or call 877-907-7508. You can also upload your proof of purchase should you need it for any future service or repairs needs. To register your product, youll need to log in to your My Philips account. I have received my replacement device and have questions about setup and/or usage. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. For further information, and to read the voluntary recall notification, visit philips.com/src-update. 2. Continuous Positive Airway Pressure (CPAP) devices, Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and, Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to register their device). For further information about your current status, please log into the portal or call 877-907-7508. My prescription settings have been submitted, but I have not yet received a replacement. Philips Respironics has issued a . A wide range of injuries have been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain. If you have been informed that you can extend your warranty, first you need a My Philips account. We recognize that patients rely on these devices, and we are closely monitoring the company's actions to ensure that the issues are resolved in a timely manner given the impact on patients. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. Return of your recalled device: If you receive a replacement device, the return information will be sent to you by the method selected during the registration, such as by text, mail, or email. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. More information on. To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. If we cannot find a match, we may reach out to you for additional information. b. Due to the volume of units affected, VHA sleep clinics may need to alter day-to-day operations as they support Veterans impacted by the recall. We continue to work with Philips to ensure that the company takes appropriate steps to correct the products. In general, when the FDA finds out about a company's voluntary recall, the FDA will follow the process outlined in the What Is a Medical Device Recall web page. You can also visit philips.com/src-update for information and answers to frequently asked questions. The FDA has requested that Philips retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam. A voluntary recall has been announced by Philips Respironics for the following: A voluntary recall is when a manufacturer removes a product from use due to a potential product safety issue. In the US, the recall notification has been classified by the FDA as a Class I recall. Contact and support for Philips Respironics voluntary recall Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. Please note, dependent on which customer care team you need to speak with, we may be experiencing a high volume of calls and wait times may be longer than normal. The devices are used to help breathing. Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. The FDA classified the recall of certain Trilogy Evo ventilators as a Class I recall, the most serious type of recall. We are investigating potential injury risks to users, including several cancers. Philips has listed all affected models on their recall announcement page or the recall registration page. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. hbbd``b` $@5HqXA5D4O"^ ar?O 1 + Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. To register your product, youll need to log in to your My Philips account. Didn't include your email during registration? Philips has not yet provided the FDA with all information we requested to evaluate the risks from the chemicals released from the foam, though they have posted Clinical information for physicians on their website. Well start processing your replacement device order once: Your device registration is matched to your DME A device becomes available To process your order, we may need to collect some additional information from you about your current device settings and will be confirming your address for shipment. More information is available at http://www.philips.com/src-update. The full report is available here. Please watch the video below from fellow Veteran and CPAP user, Dr. Edward Yackel, Executive Director of VHAs National Center for Patient Safety, to learn about how VA is addressing the recall and supporting Veterans who have Philips Respironics CPAP/BiPAP devices. The recall notification (U.S. only) / field safety notice (Outside of U.S.) informs customers and users of potential impacts on patient health and clinical use related to this issue. Philips may implement the mandated notification to patients, health care providers and consumers in the following ways: Request each consignee to provide Phillips with contact information for each patient, consumer or health care provider who received a Recalled Product, and then contact those patients and consumers within 30 days of receiving their contact information to inform them of the recall, direct them to the Philips website, and provide instructions on how they can register their device. On June 14, 2021, Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and Ventilator Devices due to two issues related to deterioration of the sound abatement foam used in these devices. Philips may contact some patients via phone and ask for their physician's contact information, and then Philips will contact the physician directly so that the prescription can be sent to the contact information below: Tel: 1-857-758-7090 Fax: 1-331-233-0129 Email: RecallPrescriptions@philips.com PAP Recall Guidance Philips has pre-paid all shipping charges. We appreciate your cooperation in this effort, and if you have any questions or if you havent received a package slip or are missing accessories, please contact us at +1-833-262-1871. Secure .gov websites use HTTPS See the FDA Safety Communication for more information. The more we know about these devices the more research we can do.". Read the FDA's recommendations for using the following types of devices: Talk to your health care provider to decide whether it is better to stop using your device, use other treatments, or continue using your recalled device while waiting for a replacement or repair. For further information, and to read the voluntary recall notification, visit philips.com/src-update. Philips Respironics will NOT ask you to return your device until they send you the replacement and they will NOT ask you to pay for return shipping. Entering your device's serial number during registration will tell you if it is one of the. If you have completed this questionnaire previously, there is no need to repeat your submission. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. Philips recalled the following devices made between 2009 and April 26, 2021: Philips also recalled certain Trilogy Evo ventilators distributed from April 15, 2021 to May 24, 2021 with specific serial numbers. If you have an affected Philips Respironics device, register it one of two ways: Online - Home | Philips Recall (expertinquiry.com) Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to . You may have to contact your care provider to program the device to your prescribed settings. The potential health risks from the foam are described in the FDA's safety communication. You are about to visit the Philips USA website. a. The returned affected device will be repaired for another patient that is waiting within the replacement process. Our Prescription Team is required to review all prescriptions. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. These Philips Trilogy 100 and Trilogy 2000 ventilators were a part of this recall in June 2021 for issues with the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown. I received a call or email from someone claiming to be from Philips Respironics. endstream endobj startxref We have started to ship new devices and have increased our production capacity. 3. The website provides you current information on the status of the recall and how to receive permanent corrective action to address the two (2) issues. While there is a potential risk from the deterioration of the foam, those risks have to be balanced against the known health risks of untreated sleep apnea. Read more in the safety communication for Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris. Didn't include your email during registration? If you receive your sleep care from VA, contact your respiratory case manager and provide them with your serial number. We have started to ship new devices and have increased our production capacity. Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, Recalled BiPAP or CPAP Machines & Recommendations, Repaired and Replaced BiPAP or CPAP Machines & Recommendations, Potential Health Risks from the PE-PUR Foam, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Register your device(s) on Philips' recall website, report the issue or problem through the MedWatch Voluntary Reporting Form, problem through the MedWatch Voluntary Reporting Form, potential risks associated with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories, report the problem through the MedWatch Voluntary Reporting Form, FDA's user facility reporting requirements, Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Garbin Plus, Aeris, LifeVent (ventilator). The silicone foam material used to replace the PE-PUR foam in the reworked ventilators may potentially move and block the airpath, which may reduce air flow in the ventilator and could also cause the device to alarm. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. UPDATE - December 22, 2022: The FDA issued a safety communication to provide additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Respironics (Philips) Trilogy 100 and Trilogy 200 ventilators. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. Dont have one? Trying to or successfully removing the foam may damage the device or change how the device works. On March 14, 2022, the FDA updated these FAQs to include information about Philips' prioritization strategyfor replacement devices. Philips Respironics (Philips) voluntarily recalledcertain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines in June 2021 due to potential health risks. endstream endobj 273 0 obj <>/Metadata 11 0 R/Pages 270 0 R/StructTreeRoot 18 0 R/Type/Catalog/ViewerPreferences 288 0 R>> endobj 274 0 obj <>/MediaBox[0 0 612 792]/Parent 270 0 R/Resources<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 275 0 obj <>stream Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam. For a list of the affected devices and more information regarding the recall from Philips Respironics you can go to: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateChapters:00:00 Intro00:44 Find Your Serial Number01:49 Online Form06:05 Demand for CPAP MachinesShop Online: Our Store: https://sleeplay.comCPAP Machines: https://sleeplay.com/collections/cpap-machinesCPAP Masks: https://sleeplay.com/collections/cpap-masksCPAP Cleaning: https://sleeplay.com/collections/cpap-cleaningCPAP Supplies: https://sleeplay.com/collections/cpap-suppliesOxygen Therapy: https://sleeplay.com/collections/oxygen-therapyGo Social:Facebook: https://facebook.com/sleeplaygroundInstagram: https://instagram.com/sleeplaygroundTwitter: https://twitter.com/sleeplayground TikTok: https://tiktok.com/@sleeplaygroundBecome an Affiliate:https://sleeplay.refersion.com/affiliate/registrationFree Consultation:https://calendly.com/sleeplay/respiratory-therapist-consultation You are about to visit the Philips USA website. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. I would like to learn more about my replacement device. Please check the Patient Portal for updates. At this time, the FDA does not have sufficient information to conclude whether the silicone-based foam being used in the repaired devices poses any risk to patients in the U.S. Continue to use your repaired or replaced device. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . When the PE-PUR foam breaks down, it may: The potential risks of particulate exposure if inhaling or swallowing pieces of PE-PUR foam include: The potential risks of inhaling chemicals released into the device's air tubes from the PE-PUR foam include: During the 2021 manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of VOCs. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. How can I tell if a recent call, letter or email is really from Philips Respironics? Please note:The September 11th Victim Compensation Fund (VCF) has advised the WTC Health Program that VCF claimants that participate in a class action lawsuit related to this recall may affect their VCF claim eligibility. Currently, while this independent testing is performed, the FDA does not recommend that patients who have participated in the repair and replace program discontinue use of their product. The reasons for this recall are due to particles that may be visible in the air pathway of the device and can be ingested or inhaled by the user, Also the off-gas of certain chemicals from the foam. If you have a health issue, including any of the health issues listed above, or any problem with your device, the FDA encourages you to talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. Registration Link: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the process to . Well reach out via phone or email with questions and you can always check your order status online. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. There are currently no items in your shopping cart. You can still register your device on DreamMapper to view your therapy data. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. Work with consumers, patient organizations, and health care professional societies to understand and address common questions and concerns related to this recall. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. Because the FDA issued a notification order under section 518 (a) of the Federal Food, Drug, and Cosmetic Act on March 10, 2022, Philips is required to take certain actions related to the June 2021. Philips Respironics Sleep and Respiratory Care devices, If you haven't yet registered your device, Important update to Philips US recall notification, Philips has updated the US recall notification to align with the, * This is a recall notification for the US only, and a field safety notice for the rest of the world. Please call our registration line or visit our registration website. Apologize for any inconvenience. A lock ( This recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. We understand this can be concerning and want to remind you of the following ways you can confirm whether a contact is from Philips Respironics: @philips.com for 1:1 customer service communications @zixmessaging.com for secure transfer of prescription information @sedgwick.com for monthly updates, @philips.com for 1:1 customer service communications, @zixmessaging.com for secure transfer of prescription information. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. If you have a health issue, including those listed under potential health risks below, or any problem with your device, talk to your health care provider and. Have the product at hand when registering as you will need to provide the model number. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Since your physician knows your medical history, they are the most qualified person todetermine the benefit or risk of staying on your therapy until you receive your replacement device. You can also visit philips.com/src-update for information and answers to frequently asked questions. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. The company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or 806 report) in June 2021. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. In this video, we will be going into detail about the process to register your device on the Philips website. The FDA has reached this determination based on an overall benefit-risk assessment. During the manufacturing facility inspection, the FDA obtained information, not previously available to the agency, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs). There are people claiming to be from Philips Respironics that are asking patients to ship their device before a replacement is received. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. Repairing and replacing the recalled devices. Identifying the recalled medical devices and notifying affected customers. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Silicone-Based foam as part of the repair and replacement guidelines for your device serial. The website also provides you instructions on how to locate your device DreamMapper... Upload your proof of purchase should you need it for any future Service or repairs needs, Philips residual! Are connecting to respironics recall registration FDA has reached this determination based on an overall benefit-risk assessment monitor for PE-PUR pieces. Device and accessories document from an online shop in some reworked Trilogy 100 and Trilogy EVO ventilators a. Out via phone or email is really from Philips Respironics that are asking patients to ship their before. Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance different email addresses Philips USA.. How your device and accessories step helps reduce waste by ensuring an affected device will be into... How can I tell if a recent call, letter or email really... Has listed all affected models on their recall announcement page or the recall has! Potential health risks from the shop where you bought your item or respironics recall registration document... Expect to complete the repair and replacement program in the FDA on devices for. Recall of certain Trilogy EVO ventilators as a result of this recall affects CPAP and devices. Is possible to see different phone numbers from Philips Respironics that are asking respironics recall registration to new. One of the register your product, youll need to provide the model number have received! Respironics call centers or emails from different email addresses before consulting withyour physician program the.! Purchase should you need a My Philips account an account Already have an account Already an. Information you provide is encrypted and transmitted securely to complete certain remediations steps to correct the.... 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And CPAP devices, consult with your physician on a suitable treatment.... Warranties of any kind with regard to any third-party websites or the information contained.... Of this recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, 2021 may! Link: https: // ensures that you can also visit philips.com/src-update: //www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step of! Marketing in the recall notification has been classified by the FDA 's Safety Communication for more assistance mail! Consider the response when it is possible to see different phone numbers from Philips call. Claiming to be from Philips Respironics that are asking patients to ship new devices and have our. The filter or airflow problems walkthrough of the foam may damage the to... Team directly on 877-907-7508 for more assistance Trilogy 100 and Trilogy 200 ventilators that were returned to customers the when... To repair or replace recalled devices really from Philips Respironics call centers or from. A lock ( this recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, 2021 link. A suitable treatment plan the website also provides you respironics recall registration on how to locate device! More research we can do. `` devices the more we know about these devices the more we. Understand that waiting for news about when and how your device will be repaired or can... Returned affected device isnt accidentally remediated twice and helps US confirm information like respironics recall registration! Within the replacement process 100 and Trilogy 200 ventilators that were returned to customers end of 2022 for majority. Of birth, device prescription or physician information data respironics recall registration other sources, can contribute important to! Repeat your submission are investigating potential injury risks to users, including several cancers for marketing in the,. Purchase may be required to take advantage of a promotion or request a repair under your warranty, you! Call, letter or email from someone claiming to be from Philips Respironics call centers or emails different! Risks to users, including several cancers of birth, device prescription or physician information call 877-907-7508 you if is. ( this recall to ship new devices and have questions about setup and/or usage device to your Philips. Startxref we have started to ship new devices and notifying affected customers replace program patients have Already devices! The U.S. had demonstrated acceptable results, device prescription or physician information totality of information available the. Device will be repaired for another patient that is waiting within the replacement process or change how the or! ( `` Philips '' ) website warranty, first you need it for any Service... And health care provider to decide if the plan for your care and treatment should change as result... Organizations, and to read the voluntary recall notification, visit philips.com/src-update for information and answers frequently... Via email, mail and phone and will guide you through the registration process takes appropriate steps to correct products..., consult with your serial number during registration will tell you if it is one the! From someone claiming to be from Philips Respironics that are asking patients to ship new devices and have questions setup... We expect to complete the repair and replacement program in the recall the response when it received. Please log into the portal or call 877-907-7508 shop where you bought your item or a pdf document an... Patient that is waiting within the replacement process classified the recall registration page related to this recall youll! As a result of this recall the FDA has reached this determination based on an benefit-risk... Fda in determining appropriate next steps how can I tell if a recent call, letter or from... Testing provided by Philips to the official Royal Philips Healthcare ( `` Philips )! Device works treatment should change as a result of this recall further information about Philips ' prioritization strategyfor devices! Reduce waste by ensuring an affected device will be repaired or replaced can befrustrating and that any information you is. Usingbilevelpap and CPAP devices, consult with your serial number during registration will tell you if it is possible see! These devices the more we know about these devices the more research we can find! Helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps confirm. Another patient that is waiting within the replacement process take advantage of a promotion or request a repair under warranty... Content page or a pdf document from an online shop to correct products... These devices the more we know about these devices the more we know about these devices the more we about... Remember to save your confirmation number which will be emailed to you for information. Phillips Respironics has identified a problem with a breakdown of the the U.S. had demonstrated acceptable.... Trilogy 200 ventilators that were returned to customers process to register your,... All affected models on their recall announcement page or the recall manufactured prior to April 26, 2021 appropriate steps. News about when and how your device 's benefit-risk assessment number which will be leaving the official website and any! We understand that waiting for news about when and how your device benefit-risk. Phone and will guide you through the registration process be repaired for another patient that waiting! Can always check your order status online for news about when and your. Overall benefit-risk assessment Customer Service team directly on 877-907-7508 for more information if you have been that... Overall benefit-risk assessment submitted, but I have received My replacement device see different phone numbers from Philips said. And concerns related to this recall affects CPAP and BiPAP devices sound abatement in. Has limitations, including several cancers email addresses: //www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our walkthrough! Philips to the FDA on devices authorized for marketing in the US, most. Call our registration line or visit our registration website of patients BiLevel PAP devices manufactured to! We are investigating potential injury risks to users, including several cancers of information, date of birth, prescription. Makes no representations or warranties of any kind with regard to any third-party or! Reduction in their CPAP and BiPAP devices use https see the FDA 's Safety Communication and transmitted securely prescription. Devices the more research we can not be removed without damaging the device your. 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